510(k) K071586 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
BIORAPTOR 2.3 PK SUTURE ANCHOR
| Applicant | Smith & Nephew Inc., Endoscopy Division, Andover MA, US |
| Decision | Substantially Equivalent, Aug 17, 2007 |
| Received | Jun 11, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2024 | Smith & Nephew Inc. BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. Open, Classified |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.